Stefanini North America and APAC is hiring: CAPA Writer in Round Lake

Stefanini Group is hiring a CAPA Writer at Round Lake, IL. Please contact Vipul Bhardwaj (call 248-263-8630 or email vipul.bhardwaj@stefanini.com) to apply.

Work Details

• Work Hours: M‑F (40 hrs)
• Shift: 1st Shift
• Location: Round Lake, IL

Responsibilities

• Perform non‑conformance (NCR) investigations within the Track Wise 8 Management System.
• Execute implementation of CAPAs associated with NCR investigations.
• Maintain a high level of expertise in current regulatory requirements and serve as a plant resource for compliance with these requirements. Maintain audit‑ready status for assigned areas and assist other areas within the facility in maintaining compliance with local procedures as well as US & International regulatory and corporate quality requirements.
• Provide guidance and coaching on DMAIC problem‑solving and process‑improvement projects for less experienced individuals within the plant.

Job Requirements

• BS/BA (4 years of university‑level education) in science, engineering, or related field.
• 2‑4 years of relevant work experience in a cGMP‑related industry or clinical setting.
• Greenbelt certification or equivalent experience using Six Sigma or other Lean manufacturing tools is a plus.
• Candidate must not be allergic to penicillins or cephalosporins.
• Understanding of the product’s intended use and manufacturing process.
• Ability to prioritize multiple tasks to ensure compliance with regulations and SOPs.
• Strong problem‑solving and analytical skills.
• Consultation and facilitation skills.
• Understanding of statistics to support fact‑based decision making.
• Excellent written and verbal communication and organizational skills.
• Ability to make independent decisions with minimal oversight.
• Customer sensitivity / acumen and ability to interact with all levels of management.
• Experienced user of TrackWise preferred.
• Working knowledge of FDA regulations and international regulatory requirements.
• Understanding of risk‑management tools.
• Availability to work during off‑shift or weekends as appropriate to support investigations and training.

Compensation: Listed salary ranges may vary based on experience, qualifications, and local market. Some positions may include bonuses or other incentives.

Stefanini takes pride in hiring top talent and developing relationships with future employees. Our talent acquisition teams conduct a phone conversation to discuss the job and the interview process before making an offer.

About Stefanini Group: A global provider of offshore, onshore, and nearshore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises worldwide. Stefanini serves clients across the Americas, Europe, Africa, and Asia in industries such as financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities.